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Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

TerminatedPhase 1, Phase 2

Sponsor: NYU Langone Health

Conditions: Pancreatic Cancer

Interventions: Oxaliplatin, 5FU, Radiation, Surgery, FOLFOX 6

Countries: United States

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
* Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator.
* No prior chemotherapy or abdominal radiation therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Clinically measurable or evaluable disease.
* Life expectancy of at least 12 weeks.
* Adequate bone marrow reserve, granulocyte count \>= 1500/uL, platelet count \>= 100,000/uL, hemoglobin \>= 9 g/dL.
* Adequate renal function with creatinine =\< 1.5 times upper limit of normal (ULN)
* Adequate biliary function with bilirubin \< 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =\< 2.5
* Age \> 18 years
* Signed informed consent.
* No known allergy to one of the study drugs
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No prior malignancy within last 5 years
* No central nervous system metastases
* No peripheral neuropathy \> grade2
* No other serious concomitant illness

Exclusion Criteria:

* Active infection or uncontrolled infection
* Presence of metastatic disease.
* Inadequate organ function as discussed above.
* Pregnancy
* Serious concomitant systemic disorder.
* Use of any investigational agent within a month of treatment

Locations (2)

New York, New York, United States
New York, New York, United States